FDA issues ‘compassionate’ permit to hospital allowing use of Ivermectin
THE Food and Drug Administration (FDA) has given a “compassionate special permit” to a hospital to use the anti-parasitic drug Ivermectin against the coronavirus disease 2019 (Covid-19).
This comes despite repeated warnings from health experts that the drug had “little to no effect” on patients with Covid-19, with the World Health Organization prohibiting its use outside of clinical trials.
According to FDA Director-General Rolando Enrique Domingo, the unnamed hospital has applied for a permit and was issued one on Thursday.
A compassionate special permit allows a hospital or a medical practitioner to use investigational drugs for off-label use as long as they report to the Department of Health and the FDA its effects on the patients.
Domingo added that there were two more applications for certificate of product registration, allowing ivermectin to be produced and sold in the market.
“Binigyan na sila ng listahan ng requirements na pwedeng isubmit para umandar ang application at ma-evaluate (They were given a list of requirements that they can submit so that the application can be evaluated),” Domingo said during the Laging Handa briefing.
Domingo reiterated that the agency is not against the use of ivermectin, as long as the process is followed on the registration of the product to assure its safety.